ITMO public health
Last update : 06/19/2012 | Version : 1 | ID : 2634
| General | |
| Identification | |
| Detailed name | PGRx : Graves' disease |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL 907.309 |
| General Aspects | |
| Medical area |
Endocrinology and metabolism Internal medicine |
| Others (details) | incident cases of Graves' disease |
| Keywords | Graves, pharmaco-epidemiology |
| Scientific investigator(s) (Contact) | |
| Name of the director | Grimaldi - Bensouda |
| Surname | Lamiae |
| Address | 10 place de Catalogne, 75014 Paris |
| Phone | 01 55 42 53 00 |
| contact@la-ser.com | |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | LA-SER |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | LA-SER |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Case control study |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Cases of Graves' disease are recruited by a network of endocrinology, internal medicine and pediatric centers, and the referents by a network of general practitioners, distributed all across the territory. |
| Database objective | |
| Main objective | Surveillance and assessment of the risk of Graves' disease associated with drug or vaccine use in real life situations. |
| Inclusion criteria |
For the cases: patients, males and females aged 0 to 49 years, having clinical or biological signs or symptoms suggesting Graves' disease declared by the specialist, for which the first symptoms of the episode occurred less than 12 months ago. For the controls: patients, males and females aged 0 to 49 years and older, having consulted a general practitioner. |
| Population type | |
| Age |
Newborns (birth to 28 days) Infant (28 days to 2 years) Early childhood (2 to 5 years) Childhood (6 to 13 years) Adolescence (13 to 18 years) Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
General population |
| Gender |
Male Woman |
| Geography area |
International |
| Detail of the geography area | France, Italy, Spain, United Kingdom, Canada |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 04/2008 |
| Size of the database | |
| Size of the database (number of individuals) |
[10 000-20 000[ individuals |
| Details of the number of individuals | - 153 cas/cases - 11125 référents/controls |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures |
| Declarative data (detail) |
Phone interview |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity |
| Procedures | |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Methods for accessing the database are currently being defined |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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